The Effects of Diet and Exercise Interventions in Peripheral Artery Disease

饮食和运动干预对周围动脉疾病的影响

• 批准号: 10445408
• 负责人: Andrew W Gardner
• 金额: $ 50.84万
• 依托单位: PENNSYLVANIA STATE UNIV HERSHEY MED CTR
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-01 至 2027-05-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10445408
• 关键词: Address; Affect; Age-Years; American; Ankle; Behavioral Paradigm; Biological Markers; Blood Vessels; Blood flow; C-reactive protein; Cardiovascular system; Cholesterol; Clinical; Comparative Effectiveness Research; Consumption; DASH diet; Data; Diabetes Mellitus; Dietary Intervention; Eating; Event; Exercise; Exercise Therapy; Functional disorder; Goals; Health; Hemoglobin; High Prevalence; Home; Hypertension; Impairment; Inflammation; Institute of Medicine (U.S.); Intervention; Investigation; Knowledge; Leg; Lower Extremity; Measures; Mediating; Metabolic syndrome; Methods; Monitor; Muscle; Obesity; Outcome; Outcome Measure; Pain in lower limb; Patients; Peripheral; Peripheral arterial disease; Persons; Physical Function; Physiological; Quality of life; Randomized; Randomized Controlled Trials; Recommendation; Risk; Risk Factors; Severities; Symptoms; Testing; Therapeutic Intervention; Time; Unhealthy Diet; Walking; Work; base; cardiovascular risk factor; claudication; clinically relevant; clinically significant; comparative effectiveness; cost; dietary; efficacy testing; exercise intervention; exercise program; fruits and vegetables; health related quality of life; improved; indexing; innovation; mortality; novel; patient oriented; primary outcome; programs; secondary outcome; standard care; standard of care; systemic inflammatory response; treatment strategy; vascular inflammation

PROJECT SUMMARY Objective. Our objective is to build on our preliminary work that demonstrates a modified dietary approaches to stop hypertension (modDASH) eating plan combined with a standard exercise program will be a better overall treatment for patients with peripheral artery disease (PAD) to improve walking, local microvascular function, and vascular inflammation. Specific Aims. We propose to test the efficacy of a modDASH dietary program combined with an exercise program (modDASH+Ex) to improve exercise and vascular outcome measures in patients with PAD and claudication beyond that of the standard treatment of an exercise program (Ex). Our central hypothesis is that the modDASH+Ex program improves the efficacy to rehabilitate PAD patients by improving exercise outcomes, health-related quality of life (HRQoL), local microvascular function, and vascular inflammation more than the standard Ex program. This clinically relevant hypothesis will be tested through the following aims: Aim 1 (Exercise Outcomes). To compare the changes in ambulation and HRQoL in PAD patients following the combined modDASH+Ex program, and following the Ex program which represents standard of care treatment. Aim 2 (Local and Systemic Vascular Outcomes). To compare the changes in local microvascular function of the lower extremities and inflammation in patients following the combined modDASH+Ex program, and following the Ex program. Aim 3. To explore the causal mechanism that changes in local microvascular function and vascular inflammation are physiologic mechanisms that precede changes in ambulation following the modDASH+Ex and Ex programs, and whether changes are more predictive following modDASH+Ex program. Methods. This is a 3-month, patient-oriented, translational, comparative effectiveness randomized controlled trial. A total of 184 patients will be randomized into either the modDASH+Ex program (N=92) or the Ex program (N=92). All patients will perform home-based walking for 3 months, and patients randomized to the modDASH+Ex program will progressively increase their daily servings of fruits and vegetables by up to 3-4 servings above baseline during the program. Clinical Significance. If successful, combining the modDASH eating plan with a home-based exercise program will be a novel and innovative behavioral paradigm to optimally improve peak walking time, HRQoL, local microvascular function and vascular inflammation in PAD patients. These improvements could impact the clinical course of PAD by reducing long-term risks of major adverse cardiovascular and lower extremity events.

项目摘要 Objective.我们的目标是建立在我们的初步工作，证明了修改饮食 方法停止高血压（modDASH）饮食计划结合标准的运动计划将是一个 对外周动脉疾病（PAD）患者进行更好的整体治疗，以改善行走、局部微血管 功能和血管炎症。 具体目标。我们建议测试modDASH饮食计划结合 运动计划（modDASH+Ex）改善PAD患者的运动和血管结局指标 和跛行超出了标准治疗的锻炼计划（Ex）。我们的核心假设是 modDASH+Ex项目通过改善运动改善了PAD患者的康复效果 结果、健康相关生活质量（HRQoL）、局部微血管功能和血管炎症更多 比标准的Ex程序更好该临床相关假设将通过以下目的进行检验： 目标1（练习结果）。比较PAD患者的Amplitude和HRQoL的变化 遵循modDASH+Ex组合计划，并遵循代表标准治疗的Ex计划 治疗 目标2（局部和全身血管结局）。比较局部微血管的变化 modDASH+Ex联合治疗后患者的下肢功能和炎症，以及 在Ex计划之后。 目标3.探讨局部微血管功能改变及血管内皮细胞凋亡的发生机制， 炎症是在modDASH+Ex治疗后Amplitude变化之前的生理机制。 和Ex程序，以及在modDASH+Ex程序之后变化是否更具预测性。 方法.这是一项为期3个月的、以患者为导向的、转化的、比较有效性的随机 对照试验共184例患者将随机分配至modDASH+Ex项目（N=92）或Ex 程序（N=92）。所有患者将进行3个月的居家步行，随机分配至 modDASH+Ex计划将逐步增加他们的水果和蔬菜的每日供应量，最多可达3-4 在项目期间超过基线的服务。 临床意义如果成功，将modDASH饮食计划与家庭锻炼相结合 该计划将是一种新颖和创新的行为模式，以最佳方式改善高峰步行时间，HRQoL，局部 PAD患者的微血管功能和血管炎症。这些改进可能会影响临床 通过降低主要不良心血管和下肢事件的长期风险，降低PAD的病程。